A fMRI Study of the Treatment of Danish Veterans With PTSD With Prolonged Exposure Therapy
NCT ID: NCT02519296
Last Updated: 2016-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-01-31
2021-01-31
Brief Summary
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Detailed Description
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Secondary outcome measures concern changes of Brain Derived Neurotrophic Factor (BNDF) and changes in the brain structure with focus on the hippocampal function using fMRI.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prolonged Exposure Therapy
In total 30 Danish veterans will be recruited, who meet the ICD-10 diagnostic criteria for PTSD, and treated with PE.
Intervention with eight sessions of PE, psychometrics, blood analyses and fMRI.
Prolonged Exposure Therapy
8 sessions with prolonged exposure therapy and fMRI.
Observation
fMRI.
fMRI
Functional Magnetic Resonance Imaging of the brain
30 Danish veterans without PTSD
A group of controls will be recruited consisting of age-appropriate same sex veterans who have participated in international missions similar to the patient group.
Observation with psychometrics, blood analyses and fMRI.
Observation
fMRI.
fMRI
Functional Magnetic Resonance Imaging of the brain
Interventions
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Prolonged Exposure Therapy
8 sessions with prolonged exposure therapy and fMRI.
Observation
fMRI.
fMRI
Functional Magnetic Resonance Imaging of the brain
Eligibility Criteria
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Inclusion Criteria
* Controls: Danish veterans without ICD-10 diagnostic criteria for PTSD
Exclusion Criteria
* Participants who consume more than 21 units of alcohol per week, and who, during the last month, have had repetitive episodes with craving, episodes of loss of control due to alcohol consumption, and a weakened ability to manage consumption, stop or reduce consumption
* Participants who have a current ICD-10 diagnosis within:
* F20 to F29 Schizophrenia
* Schizotypical mental disorder
* Delusional disorder
* Acute and transient psychotic disorders and Schizoaffective psychosis
* F30 Manic single episode
* F31 Bipolar affective disorder
* F60.2 Dyssocial personality structure
* F60.3 Emotionally unstable personality structure
* F90 Hyperkinetic disorder (ADHD) F98.8 Other behavioural and emotional disorders in childhood and adolescence (ADD)
* Participants who have a daily intake of sedative, anxiolytic
* Participants who score below 23 on the Mini Mental State Examination, and (5)
* Participants who within the last 3 months have had a serious suicide attempt.
* Ferromagnetic prostheses (including straps prostheses, clips on blood vessels, pacemakers, and metal splinters)
* claustrophobia and movements during the scan.
20 Years
35 Years
ALL
Yes
Sponsors
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Aalborg University Hospital
OTHER
Responsible Party
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Jørgen Aagaard
MD, professor, senior consultant, DrMedSc
Principal Investigators
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Morten Kjølbye, MD
Role: STUDY_CHAIR
Aalborg University Hospital
Other Identifiers
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PE-PTSD-Klinik Syd
Identifier Type: -
Identifier Source: org_study_id
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